To evaluate, by means of meta-analysis and systematic review, evidence regarding the effectiveness of psychosocial interventions for anxiety and depression in patients with prostate cancer

Databases searched were PubMed, CINAHL, PsycINFO, Cochrane Collaboration, and two Chinese databases.

A study was included in the review if it

• Was a randomized controlled trial
• Reported on patients with prostate cancer at any disease stage
• Compared psychosocial strategies to usual or standard care
• Measured anxiety and depression.

A study was excluded if it focused on disease other than prostate cancer and lacked intergroup comparison.

• A total of 8,144 references were retrieved.
• Researchers evaluated the quality of studies by using the Jadad scale.

• After evaluation, 14 studies, relating to a total of 1,484 patients, were included in the review.
• Sample range across studies/total patients included in the review was 36–400 patients.
• Patient age range was 60–76 years.
• In all but four studies, patients were newly diagnosed.

Patients were undergoing multiple phases of care.

• Interventions included education (n = 8), cognitive behavioral strategies (n = 6), counseling or psychotherapy (n = 1), and social support (n = 1).
• Analysis showed that psychosocial strategies did not have a significant immediate effect on reducing anxiety. After three months, there was a significant overall effect on reducing anxiety from two studies included in meta-analysis (SMD = –1.13, 95% CI –1.64, –0.63, p < 0.0001).
• Eight studies resulted in an overall positive effect on depression in the short term (SMD = –0.43, 95% CI –0.68, –0.18, p < 0.001). Three studies resulted in no significant effect at one-month follow-up. Across two studies, analysis showed a positive effect at three months (SMD = –0.78, 95% CI –1.54, –0.02, p = 0.04) in regard to reducing depression. There were no longer-term significant effects.
• All types of psychosocial interventions were analyzed together, with no separate analysis based on the type of intervention. Only 35.7% of studies were considered to be of high quality.

Findings suggest that psychosocial interventions can be helpful in reducing anxiety and depression, at various time points in the cancer trajectory, for men who are newly diagnosed with prostate cancer. Positive effects were generally short-term only.

• In studies examining effect on depression, depression levels were low, causing one to question the clinical relevance of statistically significant findings.
• No study required patients to have levels of depression that were clinically meaningful.
• Authors noted that the majority of studies were of low quality and with small sample size. These factors limit the confidence one can have in the findings.
• The analysis considered all types of very different interventions to be the same. This methodology did not allow researchers to determine the specific types of interventions that are truly most effective.
• Studies involved very different intervention types, different timing and frequency of intervention or follow-up, and multiple types of patient care settings. These factors make interpreting overall effectiveness difficult.

Findings of this analysis suggest that various types of psychosocial interventions can help reduce anxiety and depression in men with prostate cancer. Effects shown tended to be short-lived. Nurses can help reduce anxiety and depression among patients with prostate cancer by using psychosocial types of strategies. Information about ways to sustain this effect is limited, and the analysis does not identify the types of approaches that are the most helpful. Further exploration of longer-term sustainable effects and associated dosage and intervention frequency is needed. Given the relatively low level of quality of research in this area, more well-designed studies are needed.

To assess long-term (24-month) efficacy of biofeedback versus laxatives and bowel education.

Biofeedback training was provided in five 30-minute classes over five weeks. Similarly, laxative plus bowel education was provided in five 30-minute bowel training classes over five weeks. Those patients also took 14.6 to 22.9 g/kg of polyethylene glycol for the first six months; after six months, patients took the dose BID.

• The study reported on a sample of 109 men and women who had a history of chronic or severe pelvic floor dyssynergia (PFD) and were nonresponders to previous therapy.
• The sample comprised 54 patients in the biofeedback arm and 55 patients in the laxative arm; 53 patients per group were needed to validate significance.

Tertiary gastroenterology clinic in Verona, Italy

This was a randomized, controlled trial.

• Straining
• Sensation of incomplete evacuation
• Anorectal blockage
• Use of enemas or suppositories
• Abdominal pain
• Balloon defecation test

• At six months, major improvement was reported by 43 of 54 patients (80%) in the biofeedback group versus 12 of 55 patients (22%) in the laxative group (p < 0.001).
• Biofeedback benefits were sustained at 12 and 24 months in all measures, but not significantly.
• Patients in the biofeedback group showed greater reductions in straining, sensations of incomplete evacuation and anorectal blockage, use of enemas and suppositories, and abdominal pain (p ≤ 0.01). Stool frequency also increased in the laxative group.

Biofeedback should be the treatment of choice for PFD-induced constipation.

• The study design was not blinded.
• The sample was restricted to patients with normal whole-gut transit times; patients with delayed whole-gut transit times were excluded.
• The authors insisted the success of biofeedback greatly depends on the instructor's skill.

To compare the efficacy of biofeedback in pelvic function dyssynergia–induced constipation (PFD) versus slow transit constipation (STC).

All subjects received five weekly biofeedback lessons and were assessed at 1, 6, 12, and 24 months.

• The study reported on a sample of 75 consecutive patients who were referred to a gastroenterology clinic hospital for refractory, long-standing constipation and met inclusion criteria.
• Fifty-two patients had delayed whole-gut transit issues, 34 had PFD, and 12 had STC.

Gastroenterology Clinic of the Division of Gastrointestinal Rehabilitation of the University of Verona in Valeggio sul Mincio, Italy

This was a quasi-experimental study.

• Anorectal manometry at one and six months
• Questionnaire and balloon defecation test at 1, 6, 12, and 24 months

At six months, greater improvements were seen in patients with PFD compared to those with STC: 71% versus 8% reported improved satisfaction (p = 0.001), and 76% versus 8% reported three or more bowel movements per week (p ≤ 0.001).

Patients with PFD received greater benefit from biofeedback than those with STC.

• The sample size was small (less than 100).
• The study design was not randomized and used a two-group comparison without controls.

To examine the effects of MS-20, a fermented soybean extract, on quality of life, fatigue, and appetite for patients with cancer receiving chemotherapy (Immunologic and antioxidant profiles were also examined.)

MS 20 was taken orally on an empty stomach at a dose of 5 mL in the morning and 3 mL in the afternoon diluted in 100 mL of warm water. Patients were randomly assigned to receive MS 20 during either the first or second chemotherapy cycle after a one to two-week washout period. The study duration was eight weeks. Patients were evaluated at weekly office visits.

• N = 98  
• MEAN AGE = 56.3 years
• MALES: 63%, FEMALES: 37%
• KEY DISEASE CHARACTERISTICS: Multiple tumor types; the most common was gastrointestinal cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: Greater than 70% of patients had received previous chemotherapy.

• SITE: Single-site    
• SETTING TYPE: Outpatient    
• LOCATION: Taiwan

• PHASE OF CARE: Active antitumor treatment

Randomized, unblended, crossover trial

• European Organization for Research and Treatment of Cancer (EORTC) Quality of Life–C30 questionnaire
• Visual Analog Scale (VAS) for fatigue and appetite loss

Physical functioning scores were significantly better during treatment with MS 20 (p = .023). VAS scores for fatigue and appetite loss improved significantly while taking MS 20 (p < .001); however, fatigue and appetite loss scales on the EORTC questionnaire showed no significant difference between study conditions. There were no measurable effects on immunological parameters examined in the study.

Findings were mixed regarding the effect of MS 20 on fatigue and appetite loss.

• Small sample (< 100)
• Risk of bias (no blinding)
• Key sample group differences that could influence results
• Subject withdrawals ≥ 10%
• Other limitations/explanation: There was a greater than 40% loss to follow-up in the study for a variety of reasons; the most common were patient refusal and noncompliance. How noncompliance was determined is not clear. There is no intent to treat analysis. Patients were on a variety of chemotherapy regimens, making it difficult to evaluate efficacy well, given potential effects of different agents and dosages. The authors focus the discussion on the VAS scores showing improvement in fatigue and appetite and do not address that fact that other measurements of these symptoms showed no effect.

This study provides some mixed findings regarding the effect of MS 20, a fermented soybean extract, on fatigue and anorexia in patients during chemotherapy.

To assess the outcome and complication rate of percutaneous vertebroplasty in a large cohort of consecutive patients with myeloma and spinal metastasis treated over a nine-year period

Patients with cancer who were experiencing intractable pain from metastasis and vertebral collapse and were unresponsive to oral analgesia underwent percutaneous vertebroplasty. Pain and function were measured prior to and six weeks after the procedure.

• The study involved 128 patients who had vertebroplasty between June 2001 and June 2010. Patients who underwent the procedure prior to 2005 were evaluated retrospectively. Of the 91 patients who underwent the procedure since 2005, 50 returned completed the pre- and postprocedural pain score data, and 38 completed pre- and postvertebroplasty Rolland-Morris Questionnaires (RMQs).
• The sample characteristics were given for all 128 patients; actual study sample demographics were not stated.
  • The mean age was 60 years with a range of 31–88.
  • The sample was 53% male and 47% female.
  • Cancer diagnoses were multiple myeloma (n = 41), spinal metastasis from breast cancer (n = 22), spinal metastasis from lung cancer (n = 22), and spinal metastasis from lymphoma (n = 11).    
• Indications for vertebroplasty were intractable pain from metastasis, vertebral collapse unresponsive to oral analgesics, and as an adjunct to radiation therapy.
• Exclusion criteria were uncontrolled coagulopathy, infection, spinal cord compression, and complete vertebral collapse.

This was a single-site study conducted in the United Kingdom.

• Patients were in the advanced disease state.
• This study has clinical applicability to metastatic disease, palliative care, and late effects of treatment.

This was a prospective, intervention trial.

• Pain was measured on a 0–10 visual analog scale.
• A modified RMQ was used to measure the degree of disability on a scale of 0–23, with a higher score indicating a higher degree of disability.

• Of the 91 patients who received the procedure since 2005, 51 returned completed pre- and postprocedure pain scores.
  • Mean VAS score preprocedure was 7.57 (SD = 1.88).
  • Mean VAS score postprocedure was 4.77 (SD = 2.67) (p < 0.001).
• Of these patients, 38 completed the modified RMQ preprocedure and 6 weeks postprocedure.
  • Mean score preprocedure was 18.55 (SD = 4.79).    
  • Mean score postprocedure was 13.5 (SD = 6.95) (p < 0.001).
• VAS and RMQ scores were expressed as means with standard deviation.
• Comparison between groups was made using the Mann-Whitney U, two tailed test.
• The complication rate was 1.5%.
  • One patient experienced cement extension into the inferior vena cava.
  • One patient had a local hematoma.
  • Three patients had asymptomatic pulmonary emboli.
  • Seven patients (5%) died within 30 days of the vertebroplasty.
• The median follow-up of the group was 3 years with a range of 1–9 years.
• The Kaplan Meier estimate of 5-year survival from date of vertebroplasty for the myeloma group was 40%.
• The authors concluded that the study demonstrated that most patients with pain from spinal metastasis received rapid relief from percutaneous vertebroplasty and that disability was significantly improved.

• The study methodology did not support or made it difficult to validate authors' inferences.
• No appropriate control group was included. 
• The authors' asserted that the study showed that “most patients with pain from spinal metastasis receive rapid relief from percutaneous vertebroplasty\"; however, it wasn't clear how the authors assessed \"rapid relief\" because pain and disability appeared to only be measured at two points in time (prior to the procedure and 6 weeks after the procedure). Additionally, the results indicated that 18% of patients had no reduction or a slight increase in pain scores and 24% had no improvement in disability scores. Pain scores over a longer period of time would be helpful, such as daily for the six-week period or weekly times six weeks.
• Patients were asked to document “the worst pain during the day.” This was not clearly defined. Night pain was not assessed.  
• The study does not address what pain medications patients were taking preprocedure or if patients were taking pain medication postprocedure (e.g., opioids versus nonopioids, dosing, use of alternative medications).
• The authors did not identify what statistical tests were used to determine the validity and reliability of the modified RMQ.

Vertebroplasty can be considered as a possible option for patients with myeloma or spinal metastasis to help with intractable pain and physical disability.

To investigate the efficacy of one or more lidocaine patches in reducing incisional pain

In the initial four-week treatment phase, patients received either lidocaine patches or placebo to apply to postsurgical incisional sites. After four weeks, the lidocaine group received placebo and vice versa. Pain was rated at baseline and at four and eight weeks.

• The sample was composed of 28 patients. 
• Mean patient age was 61.9 years.
• Nineteen patients (68%) were female. Nine patients (32%) were male.
• Eligible patients
  • Had experienced pain for one month or longer, and the pain rating was equal to or greater than 4.
  • Had pain with neuropathic features (e.g., burning, paresthesias, allodynia), pain involving an area that could be covered by three patches or fewer, pain related to a surgical site associated with cancer treatment.
  • Were at least 18 years old and had no recent history of drug or alcohol abuse.
  • Were expected to live for a period longer than six months.
  • Had no evident cognitive or psychiatric morbidity.
  • Were neither pregnant nor nursing.
• Patients were ineligible if their condition involved nonsurgical pain etiologies (e.g., malignancy, dermal pathology,  chemotherapy-induced neuropathy) at the painful site.

• Multisite
• Ten clinical centers
• United States

Double-blind, randomized, two-period crossover trial

• Rating of pain intensity
• Brief Pain Inventory (Short Form) (BPI-SF)
• Neuropathic Pain Scale (NPS)
• Patients' Global Impression of Change Scale
• Short-Form McGill Pain Questionnaire (SF-MPQ)
• Pain Catastrophizing Scale
• Profile of Mood States Short Form
• North Central Cancer Treatment Group Patient Quality-of-Life Linear Analog Self-Assessment Scale

• Average weekly pain intensity ratings were not significantly lower while patients used the lidocaine patch versus the placebo.
• BPI-SF interference scores were lower in patients receiving the lidocaine patch in the first period: general activity (p = 0.02), work (p = 0.04), relations with others (p = 0.02).

Pain interference scores were significantly lower in the group that received lidocaine patch first. Significant differences in postsurgical pain intensity, with the lidocaine patch applied to incisional areas, were lacking overall.

• The number of patches used varied.
• The study lacked power.
• Patients self-reported pain by means of telephone and email. Patients applied the patches themselves; whether they applied them correctly is unclear.
• In regard to weekly measures: Change may have occurred at times when measurements were not taken.

Further research is needed to determine whether lidocaine patches augment the analgesic regimen for incisional pain.

To report the effects of a strength training and walking program in patients with stage IV lung and colorectal cancer.

Patients were given usual care or 1.5 hours of training by a physical therapist on rapid, easy, strength training exercises (REST) and pedometer-based walking using an instruction manual, resistance bands, an exertion rating scale, and a study log. They were then followed bimonthly by telephone for eight weeks.

• The study reported on a final sample of 56 patients.
• Mean patient age was 63.8 years in the intervention group and 65.5 years in the control group.
• The intervention group was 48.5% male and 51.5% female. The control group was 57.6% male and 42.4% female.
• Patients had stage IV lung or colorectal cancer.

• Single site 
• Outpatient setting
• Mayo Clinic

Patients were undergoing the end of life phase of care.

The study was a single-blinded, randomized, controlled trial.

• Activity Measure for Post-Acute Care Computerized Adaptive Testing (AM-PAC CAT)
• AM-PAC Mobility
• Functional Assessment of Cancer Therapy-General (FACT-G)
• FACT-Fatigue (FACT-F) subscale
• Numerical rating scale for pain and sleep quality
• Pedometer step-count logs
• REST logs
• Vital sign collection

Mobility, fatigue, and sleep measures were statistically significant between the intervention and control groups from baseline to week 8 (p = 0.002, p = 0.03, and p = 0.002, respectively), in favor of exercise. Other measures did not show significance. The number of REST sessions and weeks logged with step counts were associated with changes in the mobility score. Survival and withdrawals did not differ significantly between the groups.

A home-based intervention using walking and strength exercises may improve mobility, fatigue, and sleep quality in patients with stage IV colorectal or lung cancer.

• The study had a small sample size, with less than 100 participants.
• The study had risks of bias due to no blinding and no appropriate attentional control condition.

The teaching of walking exercises and strength routines may improve functioning in this patient population in terms of mobility, sleep quality, and fatigue. The one-time education session may be appealing to nurses looking for a timely intervention to help improve these symptoms.

To describe the feasibility of delivering a structured physical therapy (PT) program as part of a multidisciplinary intervention to patients undergoing outpatient radiotherapy for advanced cancer.

Patients were randomly assigned to receive the structured intervention or standard care using a stratified approach based on Eastern Cooperative Oncology Group (ECOG) performance status, age, sex, and tumor type. The structured multidisciplinary intervention consisted of eight sessions delivered by a PT and a psychiatrist or a psychologist with facilitation provided by an advanced practice nurse, licensed social worker, or certified hospital chaplain depending on the theme. Cognitive, emotional, social, and spiritual dimensions of the intervention centered on specific topics and coping strategies related to patients' goal setting, challenging negative thoughts, communication, and hope. PT sessions incorporated education and provision of printed material, truncal and upper-limb strengthening exercises, and lower-limb strengthening alternating between standing and seated exercises. These were performed with resistance provided by elastic bands. Aerobic conditioning was not included, although patients were encouraged to engage in regular physical activity. Standard care consisted of regular assessment of treatment toxicities. Patients were not counseled regarding the potential benefits of exercise.

This report focused on the PT and interdisciplinary structured intervention aspects of a previously reported study (Rummans et al. 2006).

• The study was comprised of 103 patients (59%–69% male) receiving radiotherapy for two weeks or longer who received no more than one treatment at the time of study entry.
• Age was 59.4–59.7 years. 
• The highest percentage of patients had gastrointestinal cancer; the sample also included head and neck, lung, brain, and other cancers
• Of the patients, 59%–63% were also receiving chemotherapy, 78%–89% were married, 32% were fully active performance status, and 55% were currently employed.
• Patients were included if they had an ECOG performance status of three or greater and had recurrent disease following a six-month disease-free survival.
• Radiation doses ranged from 3000 to 7200 cGy.

• Single site
• Mayo Clinic

The study was a single-blind, randomized, controlled trial.

• Spitzer Uniscale used for quality of life (QOL) measurement
• Linear analog scales (0–10) for self-assessment of physical well-being and fatigue. These scores were subsequently converted to a 100-point scale.
• Profile of Mood States (POMS) Short Form Vigor and Fatigue subscales
• 30-minute walk

• Six patients were not eligible for analysis due to missing more than four PT sessions.
• Attendance rates for the entire cohort were 89.3%.
• Mean scores after approximately one week of the intervention differed significantly between the intervention and control groups only in overall physical well-being (p = 0.02).
• Changes from baseline were not different between the two groups in any measure at weeks 8 and 27.
• Approximately half of the intervention group declined functionally despite participation in the structured program.

The structured intervention appeared to provide short-term improvement in overall perception of well-being; however, this effect was not sustained over the duration of the trial.

• No commonly used fatigue measures were reported.
• The authors reported improvement in fatigue; however, the measure was actually patient perception of overall well-being.
• There was no attentional control group for comparison.
• The 50% decline in function for patients in the intervention group points to the need to determine which patients might benefit the most from such an intervention and what type of exercise or combined intervention is most effective.
• The study assessed subjective physical well-being rather than objective performance or the specific phenomenon of fatigue.

To examine progressive muscle relaxation training (PMRT) in reducing anxiety and improving quality of life in patients with colorectal cancer after stoma surgery

PMRT was provided for 20 minutes along with deep breathing (10 major muscle groups were used, but not valsalva response). Participants received two teaching sessions and practiced at home for 10 weeks. Measurements were taken during hospitalization and 5 and 10 weeks after surgery and intervention.

The study reported on a sample of 59 participants.

The sample was recruited from the department of surgery of two public hospitals in Hong Kong.

A longitudinal randomized controlled trial design was used.

• State-Trait Anxiety Inventory (Chinese version)
• Quality of Life Index for Colostomy Patients (Chinese translation)
• World Health Organization Quality of Life measure–abbreviated (Hong Kong Chinese version)
• Medical/social/demographic data, including frequency of home practice of PMRT

R-ANOVA indicated there was a significant difference in state-anxiety over the 10 weeks between the two groups (p < 0.01), with the experimental group reporting a significantly lower state-anxiety level than the control group. Also, scores significantly decreased over time (10 weeks) in both groups (p < 0.001), indicating a 43% decrease.

• No baseline assessment was performed preoperatively.
• PMRT is time-consuming and labor intensive.

To determine the effectiveness and safety of viral vaccines in patients with hematologic malignancies. The primary outcome was the incidence of infection. Secondary outcomes were mortality, incidence of complications, severe viral infection, hospitalization, immune response, and adverse effects.

Databases searched were the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and CINAHL (June 2010). In addition, reference lists of relevant articles, abstracts from scientific meetings, and contacted vaccine manufacturers were used.

Randomized, controlled trials (RCTs) evaluating viral vaccines in patients with hematologic malignancies were included. No exclusion criteria were stated.

A total of 565 references were retrieved.

Relative risk (RR) was used for binary data, and mean difference (MD) was used for continuous data. The fixed-effect model was used in meta-analyses. Two authors (first and second authors) independently reviewed titles and abstracts of references retrieved from the searches and selected all potentially relevant studies. Copies of these articles were obtained and reviewed independently by the same authors against predefined inclusion criteria. The authors were not blinded to the names of the trial authors, institutions, or journal of publication. All disagreements about the selection of studies were resolved by consensus.

Interventions evaluated included heat-inactivated varicella-zoster virus (VZV) vaccine (two trials), influenza vaccines (five trials), and inactivated poliovirus vaccine (IPV) (one trial).

• The final study sample included eight RCTs.
• Three hundred five patients were in intervention groups and 288 were in control groups.  
• Sample sizes across studies ranged from 25 to 182.
• Patients of all ages with hematologic malignancies, including acute and chronic leukemias, lymphomas (Hodgkin and non-Hodgkin), and myelomas, were included. Trials evaluating all forms of viral vaccines, including influenza, varicella, hepatitis A, hepatitis B, measles, mumps, rubella, and poliomyelitis, were included in the review. The control interventions could be placebo vaccine, no vaccine, an alternative form of vaccine, or alternative dosing regimens or schedules.

Patients were undergoing the active treatment phase of care.

The VZV vaccine might reduce herpes zoster compared with no vaccine (relative risk [RR] = 0.54; 95% confidence interval [CI] [0.3, 1.0]; p = 0.05). Vaccination also demonstrated efficacy in immune response but frequently caused local adverse effects. One trial reported a severity score of zoster that favored vaccination (MD = 2.6; 95% CI [0.94, 4.26]; p = 0.002). Two RCTs compared inactivated influenza vaccine with no vaccine and reported a lower risk of lower respiratory infections (RR = 0.39; 95% CI [0.19, 0.78]; p = 0.008) and hospitalization (RR = 0.17; 95% CI [0.09, 0.31]; p < 0.00001) in vaccine recipients. However, vaccine recipients more frequently experienced irritability and local adverse effects. There was no significant difference in seroconversion between one and two doses of influenza vaccine (one trial), or between recombinant and standard influenza vaccine (one trial), or influenza vaccine given with or without reinduction chemotherapy (one trial). The IPV trial comparing vaccination starting at 6 versus 18 months after stem cell transplantation (SCT) found no significant difference in seroconversion.

Inactivated VZV vaccine might reduce zoster severity in adult SCT recipients. Inactivated influenza vaccine might reduce respiratory infections and hospitalization in adults with multiple myeloma or children with leukemia or lymphoma. Local adverse effects occur frequently.

The quality of evidence is low.

Further high-quality RCTs are needed.